Clinical trials: Serious Adverse Events
Contraception
Safety,Effectiveness and Acceptability of Sino-implant II in DR
A study to assess the contraceptive effectiveness of Sino-implant (II).
- Trial name
- NCT01594632
- Testing
- Jadelle, Sino-implant (II)
- Where
- Dominican Republic
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- FHI 360
Adverse Drug Reaction
Serious Adverse Drug Reaction and Their Preventability
Introduction: Elderly aged over 65 years accounted for around 17.5% of the French general population. Adverse drug reactions (ADR) are common in this population. In elderly subject, prevalence of ADRs ranged from 4.3% to 63.0%.
- Trial name
- SADR (NCT02888834)
- Testing
- Adverse drug reaction
- Where
- France
- Volunteers
- 100 people
- Sponsor
- CHU de Reims
Schizophenia Disorder, Schizoaffective Disorder
Reduction of Anticholinergic Medications Among Persons With Schizophrenia or Other Psychiatric Disorders
The goal of this study is to reduce Anticholinergic Medication (ACM) in persons with psychoses or serious mental illness, when these medications are no longer needed.
- Conditions
- Schizophenia Disorder, Schizoaffective Disorder, Bipolar Disorder, Psychiatric Disorders
- Trial name
- RAMP (NCT07043803)
- Testing
- Reduction of anticholinergic medication
- Where
- 4 sites in United States
- Volunteers
- 53 people
- Sponsor
- University of Pittsburgh
Older Adults (65 Years and Older), Chronic Kidney Disease (CKD)
Pramipexole and the Risk of Serious Adverse Events
This is a population-based cohort study assessing whether initiation of a higher dose of pramipexole (0.25 or 0.375 mg/day), compared with a lower dose (0.125 mg/day), in older adults with advanced chronic kidney disease (CKD)…
- Trial name
- NCT07382960
- Testing
- Pramipexole
- Where
- Canada
- Volunteers
- 1,100 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
HIV Infections
Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV
This Phase 2 study involving tenofovir disoproxil fumarate (TDF) will assess the extended safety of TDF 300 mg per day among young women who are not HIV-infected.
- Trial name
- NCT00122486
- Testing
- Tenofovir Disoproxil Fumarate
- Where
- 3 sites in Cameroon, Ghana and 1 more
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- FHI 360
Syncope
Hypersensitive Troponin Performance to Identify Syncope at Risk of Serious Adverse Events in the Short Term
Syncope, a frequent reason for emergency room visits and hospitalization, is a symptom of three major etiological entities: cardiac causes, vaso-reflex causes and orthostatic hypotension.
- Trial name
- TROPOCOPE (NCT03528161)
- Testing
- Measurement of hypersensitive troponin
- Where
- France
- Volunteers
- 248 people
- Sponsor
- University Hospital, Toulouse
Chronic Kidney Disease (CKD)
Domperidone and the Risk of Serious Adverse Events
This study will assess whether initiating domperidone at doses ≥30 mg/day compared to <30 mg/day in patients with advanced chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR] <45 mL/min/1.73 m² but not…
- Trial name
- NCT07098078
- Testing
- Domperidone (drug)
- Where
- Canada
- Volunteers
- 15,000 people, healthy volunteers welcome
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Cardiac Surgery, Heart Surgery
Safety and Performance Evaluation of CPB Venous and Arterial Cannulas
This is a two-phase study evaluating the Eurosets arterial and venous cannulas for use during cardiopulmonary bypass (CPB) procedures. Phase 1 is a pilot study focused on assessing cannula safety.
- Conditions
- Cardiac Surgery, Heart Surgery, Cardiopulmonary Bypass, Coronary Surgery
- Trial name
- NCT07354841
- Testing
- Eurosets Venous and Arterial Cannula, Control Arterial and Venous Cannulas
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- Eurosets S.r.l.
Ebola Virus Disease, Marburg Virus Disease
Evaluation of Safety, Tolerability and Immune Responses of Ebola-S and Marburg Vaccines in Healthy Adults
Primary Objective: To evaluate the safety and tolerability of cAd3-EBO-S and cAd3 Marburg vaccines when administered Intramuscular (IM) at a dose of 1 x 10^11 particle units (PU) to healthy adults.
- Trial name
- NCT04723602
- Testing
- cAd3-Marburg, cAd3-EBO-S
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Albert B. Sabin Vaccine Institute
Acute Ischemic Stroke
Imaging Guided Patient Selection for Interventional Revascularization Therapy
The primary objective of this clinical evaluation is to determine the safety and effectiveness of the Penumbra System in a stroke cohort who presents within 8 hours from symptom and with a known core infarct volume at admission.
- Trial name
- START (NCT00963989)
- Testing
- Penumbra System
- Where
- United States
- Volunteers
- 146 people
- Sponsor
- Penumbra Inc.
Obesity
Timely Detection of Treatment Emergent Serious and Non-serious Adverse Events for Saxenda® in Mexican Patients
This trial is conducted in North America. The aim is to investigate timely detection of pancreatitis cases as well as cases of suspicion of serious and non-serious adverse reactions possibly or probably related to Saxenda® in…
- Trial name
- NCT02773355
- Testing
- liraglutide 3.0 mg
- Where
- 14 sites in Mexico
- Volunteers
- 27 people
- Sponsor
- Novo Nordisk A/S
Coronary Artery Disease
Drug-Eluting Stenting Followed by Cilostazol tREAtment Reduces SErious Adverse Cardiac Events (DECREASE-PCI)
The DECREASE-PCI trial is a prospective, randomized, placebo controlled, double-blind, phase 4 study to evaluate efficacy and safety of triple anti-platelet therapy compared with dual antiplatelet therapy in patients treated with…
- Trial name
- NCT01346865
- Testing
- Cilostazol
- Where
- 12 sites in South Korea
- Volunteers
- 402 people
- Sponsor
- Seung-Jung Park
Chronic Kidney Disease (CKD)
Lorazepam and the Risk of Serious Adverse Events
This is a population-based cohort study assessing whether initiating a new outpatient prescription of a higher dose of lorazepam (>1-4 mg/day) compared to a lower dose (0.5-1 mg/day) in older adults with low kidney function (an…
- Trial name
- NCT07179978
- Testing
- Lorazepam
- Where
- Canada
- Volunteers
- 12,308 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Atrial Fibrillation, Assessment of Serious Advers Events
Prospective Registration and Assessment of Serious Adverse Events Within the AFNET
Prospective registration and independent assessment of SAE associated with atrial fibrillation such as thromboembolic events, and other cardiac and noncardiac complications by a Critical Event Committee.
- Conditions
- Atrial Fibrillation, Assessment of Serious Advers Events, Thromboembolic and Bleeding Complications, Complications of Antiarrhythmic Drugs or Invasive Procedures
- Trial name
- AFNET A7 (NCT01678456)
- Where
- Germany
- Volunteers
- 13,000 people
- Sponsor
- Atrial Fibrillation Network
Contraception
PK of Depo SubQ Injected in the Upper Arm
A single-arm trial to demonstrate that Depo-SubQ Provera injected in the upper arm is adequate for effective contraception
- Trial name
- NCT01143207
- Testing
- Medroxyprogesterone acetate
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- FHI 360
HIV
Comparison of Two Intrauterine Devices (IUDs) Among Cape Town HIV-positive Women
This study will inform international medical guidelines as to whether the Levonorgestrel intrauterine device (LNG IUD), a highly effective long-acting reversible contraceptive method, is safe and acceptable as compared to the…
- Trial name
- NCT01721798
- Testing
- Mirena levonorgestrel IUD, Copper T-380a IUD
- Where
- South Africa
- Volunteers
- 199 people, healthy volunteers welcome
- Sponsor
- FHI 360
Contraception
Long-Acting Reversible Contraception
In the proposed study, women aged 18-29 seeking oral or injectable contraception will be offered an opportunity to try LARC instead; the FDA-approved options include two types of intrauterine products and one type of subdermal…
- Trial name
- LARC (NCT01299116)
- Testing
- DMPA, oral contraceptives, Implanon®
- Where
- United States
- Volunteers
- 916 people, healthy volunteers welcome
- Sponsor
- FHI 360
Contraception
Acceptability of Depo-subQ in Uniject
This is an observational study to assess the experience of current depot medroxyprogesterone acetate (DMPA) intramuscular (IM) clients and providers when they try Depo-subQ in Uniject and offer recommendations for the…
- Trial name
- NCT01667276
- Where
- 2 sites in Senegal, Uganda
- Volunteers
- 476 people, healthy volunteers welcome
- Sponsor
- FHI 360